FDA Policy/General

Report: Three Finalists Emerge in Next Commissioner Search

Three candidates have emerged as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar with the selection process. Axios reported that Heidi Overton, deputy director of the White House Domestic Policy Council; Jeffrey Vacirca, chief executive officer of New York Cancer & Blood Specialists; and Stephen Ferrara, the Pentagon's principal deputy assistant secretary for health affairs, are currently being vetted for the position.

The White House is seeking a permanent leader for FDA following the departure of former commissioner Marty Makary. The next commissioner will inherit an agency that has been working to rebuild relationships with the pharmaceutical industry and restore staffing following months of leadership turnover and organizational disruption.

According to Axios, Overton and Vacirca had previously been identified as potential candidates by Bloomberg, while Ferrara's candidacy has not previously been reported.

According to Axios, sources familiar with the selection process expressed the greatest enthusiasm for Ferrara, citing his leadership experience. One source told the publication that Overton's selection could "spook investors, industry, and FDA career staff" because of concerns that it could prolong the uncertainty and internal turmoil associated with Makary's tenure. The same source said Ferrara and Vacirca are viewed as having stronger management credentials, although both are less well known in FDA circles.

Axios reported that it remains unclear when President Donald Trump will make a final decision or formally announce a nominee.

Whoever is selected will require Senate confirmation, joining several other pending Trump administration health nominees awaiting congressional consideration. The confirmation process could prove more challenging given the approaching election season.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome